BEUDAMED
    FDA Enforcement Class II Ongoing

    DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

    Recall: Z-0116-2024 · Reported October 25, 2023

    Enforcement

    Recall Number
    Z-0116-2024
    Event ID
    93078
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 25, 2023
    Initiation Date
    September 18, 2023
    Classification Date
    October 16, 2023
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

    Reason

    DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.

    Code Info

    UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027

    Distribution

    Pennsylvania

    Quantity

    32 kits